The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights

Edema Leg Clinical Trial

Official title:

The Effect of Compression Stockings on Edema and Discomfort During Short Haul Flights: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546725
• Other study ID #: 8392100
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: May 26, 2018

Study information

• Verified date: June 2018
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compression stockings have beneficial effects on the development of venous thromboembolic complications and oedema during long- haul flights. A randomized controlled trial investigating the effect of compression stockings during short-haul flights with a duration less than fur ours is lacking. Deep vein thrombosis is very rare on flights shorter than four hours, but compression stocking could have beneficial effects on other outcomes. The aim of this study is to assess if compression stockings used during a 3-3.5-hour flight will decrease leg edema and discomfort.

Description:

All participants will be adults who will undergo a 3-3.5 hours flight. Participants have received oral and written information about the trial. All compression stockings have a class two compression level (corresponding to 23-32 mmHg compression). Participants will be randomized to wear a compression stocking on one leg, while the other side acts as control. Within an hour preflight, the patient will measure ankle and calf circumference at marked circumferential areas on the leg and answer questionnaires regarding leg pain and subjective discomfort, whereafter the stocking will be put on, on the randomized side. Within one hour after the flight the stocking will be removed and patients will once again measure the ankle and calf circumference at the marked circumference and fill out the questionnaire.

Sample size: Mean difference in ankle circumference set to -0.19 cm. Standard deviation of the mean difference set to 0.3, 5% alfa and 80% power. Sample size with a paired design = at least 18 participants. However, for practical reasons we will include up to approximately 50 adults in the trial.

Withdrawal and dropout criteria: All participants can withdraw their consent at any point during the trial, without the need for explaining any reasons for withdrawal. Since compression stockings do not cause side effects, except for patients with severe arterial insufficiency in the legs, we do not expect the trial to be stopped due to complications. All withdrawals will be accounted for in the scientific publication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 26, 2018
• Est. primary completion date: May 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants = 18 years of both sexes. Otherwise no restriction, since each participant acts as their own control.

Exclusion Criteria:

• Any condition requiring compression stockings during short-haul flights. Severe arterial insufficiency in the lower extremities.

Related Conditions & MeSH terms

• Edema
• Edema Leg

Intervention

Device:
• Compression stocking
Compression stocking with length below the knee and a class two compression level (corresponding to 23-32 mmHg compression).

Locations

Country	Name	City	State
Denmark	Center for Perioperative Optimisation, Department of Surgery, Herlev og Gentofte Hospital, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ankle edema	Difference in ankle circumference pre- and post flight on the leg with and the leg without compression stocking.	Ankle circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.
Secondary	Calf edema	Difference in calf circumference pre- and post flight on the leg with and the leg without compression stocking.	Calf circumference on the leg wearing a compression stocking and the leg not wearing compression stocking is measured up to one hour before, and one hour after flight.
Secondary	Leg pain	Self-reported assessment of leg pain on a Visual Analogue Scale.	Leg pain is reported up to one hour before, and one hour after flight.
Secondary	Leg discomfort	Self-reported assessment of leg discomfort on a Visual Analogue Scale.	Leg discomfort is reported up to one hour before, and one hour after flight.